BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3210858 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06734
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE REMAINS IN SERVICE. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED FROM BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ON THE FAULT CODE 1003. IF A REVISION PROCEDURE IS PERFORMED AND THE PRODUCT RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDER GO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN SERVICE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT RECEIVED THE MEMORY DUMP AND CONCLUDED THAT A LOW_VOLTAGE FAULT WAS DECLARED ON (B)(6) 2013 DUE TO 3 DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THERE ARE NO OTHER SUSPICIOUS FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE VOLTAGE IS CURRENTLY 2.910 VOLTS, AND THERAPY DELIVERY IS UNAFFECTED. IN ADDITION, THE DEVICE COULOMB COUNTERS AND POWER LEVELS ARE IN LINE WITH NOMINAL VALUES. THE AGENT CONCLUDED THAT THE DEVICE IS MALFUNCTIONING AND SHOULD BE REPLACED AND RETURNED FOR ANALYSIS. TO DATE, THE BEHAVIOR OF THE DEVICE APPEARS CONSISTENT OVER TIME. THIS, HOWEVER, MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY, WHICH IS WHY A REPLACEMENT WAS RECOMMENDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITOR(S) THAT ARE CONNECTED TO THE DEVICE¿S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT A REPLACEMENT PROCEDURE. THE DEVICE WAS SUCCESSFULLY REMOVED AND REPLACED BY AN ENERGEN DEVICE, F141, SN (B)(4). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED F1O2 IS BEING RETURNED TO BSC FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, AN INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED FAULT CODE 1003 WHICH INDICATED THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY OF THE DEVICE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED TO REVIEW THE DEVICE INFORMATION AND EXPLAIN THE ALERT. THE DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311611 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening